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PROPHYLOXITIN-Intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: a multicentre, double-blind, randomized controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515146-16-00
Acronym
PROPHYLOXITIN
Enrollment
2000
Registered
2024-08-20
Start date
2023-05-15
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal surgery

Brief summary

Proportion of patients with any SSI within 30 days after surgery.

Detailed description

Proportion of patients with each type of SSI (superficial, deep and/or organ–space infection), Proportion of patients with surgical reintervention, Proportion of patients with anastomotic leak, Proportion of patients with postoperative complication according to the Dindo and Clavien classification, Proportion of patients with Clostridium difficile infection, Hospital readmission censored at day 30, Unexpected admission to the ICU censored at day 30, Duration of hospital stay and hospital free days, All-causes mortality, Proportion of per operative adverse events

Interventions

DRUGCHLORURE DE SODIUM 0
DRUGsolution pour perfusion
DRUGCEFOXITINE PANPHARMA 1 g
DRUGpoudre pour solution injectable (IV)

Sponsors

Centre Hospitalier Universitaire De Poitiers
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of patients with any SSI within 30 days after surgery.

Secondary

MeasureTime frame
Proportion of patients with each type of SSI (superficial, deep and/or organ–space infection), Proportion of patients with surgical reintervention, Proportion of patients with anastomotic leak, Proportion of patients with postoperative complication according to the Dindo and Clavien classification, Proportion of patients with Clostridium difficile infection, Hospital readmission censored at day 30, Unexpected admission to the ICU censored at day 30, Duration of hospital stay and hospital free days, All-causes mortality, Proportion of per operative adverse events

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026